EUCTR2020-004652-15-FR进行中（未招募）1 期
AVAJAK: Apixaban/rivaroxaban Versus Aspirin for primary prevention of thrombo-embolic complications in JAK2V617F-positive myelo-proliferative neoplasms - AVAJAK
CHRU de Brest0 个研究点目标入组 1,340 人开始时间: 2021年4月16日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,340
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Patients with diagnosis of PV or ET or PreMF according to WHO or BSCH criteria (bone marrow biopsy not compulsory).
- •- Patients with JAK2V617F mutation (threshold allele burden > 1%).
- •- Patients considered as high-risk” patients:
- •1°) based on age (> 60-year-old)
- •2°) based on thrombotic history (compatible with antithrombotic randomization) but aged = 18-year-old.
- •- Length of time from MPN diagnostic to inclusion will not exceed 12 months.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Contra-indication to aspirin or DOAC due to allergic situation or recent history of major bleeding
- •- Formal indication of treatment with LDA or DOAC (thus precluding randomization)
- •- Inability to give informed consent
- •- Patients under curatorship/guardianship
- •- Concomitant use of a strong inhibitor or inducer of CYP3A4 (like Ruxolitinib).
- •- Chronic liver disease or chronic hepatitis
- •- Renal insufficiency with creatinine <25 ml/mn on Cockcroft and Gault Formula
- •- Patient considered at high-risk of bleeding
- •- Active or expected pregnancy
- •- No effective contraception in women of childbearing age
- •- PS>2 or life expectancy <12 months
研究者
相似试验
进行中（未招募）
1 期
Apixaban/rivaroxaban Versus Aspirin for primary prevention of thrombo-embolic complications in JAK2V617F-positive myeloproliferative neoplasmsCTIS2024-515362-13-00Centre Hospitalier Regional Et Universitaire De Brest1,008
进行中（未招募）
1 期
Aspirin® plus rivaroxaban versus rivaroxaban alone for the prevention of venous stent thrombosis in patients with post-thrombotic syndrome (long-term condition associated with redness, swelling, leg pain, and ulcers as a results of deep vein thrombosis)Post-thrombotic syndromeEUCTR2019-001723-12-ATniversitätsspital Zürich, Klinik für Angiologie316
进行中（未招募）
1 期
Aspirin® plus rivaroxaban versus rivaroxaban alone for the prevention of venous stent thrombosis in patients with post-thrombotic syndrome (long-term condition associated with redness, swelling, leg pain, and ulcers as a results of deep vein thrombosis)Post-thrombotic syndromeEUCTR2019-001723-12-DEniversitätsspital Zürich, Klinik für Angiologie316
招募中
3 期
Rivaroxaban in Embolic Stroke of Undetermined Source(ESUS)Cerebral infarctionIRCT20200112046094N1Mazandaran University of Medical Sciences40
招募中
3 期
Effect of rivaroxaban versus apixaban on treatment of cerebral venous thrombosisIRCT20120215009014N451Hamedan University of Medical Sciences32